Senators Question FDA's Authority To Use 'Placeholder' Biosimilar Name

Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March. The lawmakers say: “FDA has not provided sufficient...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.